The FDA has proposed codifying procedures and timeframes of supervisory review of significant medical device decisions in the Center for Devices and Radiological Health (CDRH). These regulations will conform to requirements in both the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144) and the 21st Century Cures Act (Cures Act) (P.L. 114-255). The agency is also taking steps to adjust regulations to meaningfully reduce operational burdens under Executive Orders 13771 and 13777 (Proposed rule, 83 FR 2388, January 17, 2018).
Internal review. The proposed regulations would codify (1) procedures and timeframes for appeals of "significant decisions" established under section 517A of the federal Food, Drug and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq) and (2) the interpretation of key provisions of section 517A related to supervisory review. The agency believes that these regulations will increase clarity for internal and external stakeholders on CDRH’s processes and provide predictability by establishing binding deadlines for agency action.
Section 517A provides that anyone may request supervisory review of any significant CDRH decision regarding (1) the submission or review of a report under section 510(k); (2) an application under section 515; (3) a request for designation under section 515C; (4) or an application for an exemption under section 520(g). The review may be conducted at the next supervisory level or higher above the original significant decision-maker.
The FDA proposes using the term "517A decision" as opposed to the term "significant decision" in order to avoid the implication that other decisions are not significant. The following will be considered 517A decisions:
- 510(k): Not substantially equivalent; Substantially equivalent;
- PMA/HDE: Not approvable; Approvable; Approval; Denial;
- breakthrough devices: Expedited access pathway (Ref. 7) program request for breakthrough designation for devices subject to premarket notification, premarket approval, or de novo requests. Grant; Denial of request for breakthrough designation;
- IDE: Disapproval; Approval;
- failure to reach agreement on protocol under section 520(g)(7); and
- "clinical hold" determinations under section 520(g)(8).
Timeframes. A request for supervisory review of a 517A decision must be received by CDRH no later than 30 days after the date of the decision. For most requests, the FDA will render a decision within 45 days. The person requesting supervisory review may also request an in-person meeting or teleconference with the supervisor reviewing the request. Such meetings will be scheduled within 30 days, and decisions will be rendered within 30 days of the meeting. These timeframes do not apply if a matter related to the decision under review is referred to external experts.
The agency acknowledged that some parties may submit requests for decisions other than 517A decisions. Requests for supervisory reviews not for 517A decisions must be received within 60 days, unless CDRH permits the request to be filed later for good cause.
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